The Journal of Pediatrics
Volume 156, Issue 4 , Pages 556-561.e1 , April 2010

Two-Year Neurodevelopmental Outcomes of Ventilated Preterm Infants Treated with Inhaled Nitric Oxide

  • Michele C. Walsh, MD, MSE

      Affiliations

    • Case Western Reserve University, Cleveland, OH
    • Corresponding Author InformationReprint requests: Michele C. Walsh, MD, MSE, Rainbow Babies & Children's Hospital, Case Medical Center, MS 6010, 11100 Euclid Ave, Cleveland, OH 44106-6010.
    • ,
  • Anna Maria Hibbs, MD, MSCE

      Affiliations

    • Case Western Reserve University, Cleveland, OH
    • ,
  • Camilia R. Martin, MD

      Affiliations

    • Harvard Medical School, Boston, MA
    • ,
  • Avital Cnaan, PhD

      Affiliations

    • National Children's Medical Center, Washington, DC
    • ,
  • Roberta L. Keller, MD

      Affiliations

    • University of California at San Francisco, San Francisco, CA
    • ,
  • Eric Vittinghoff, PhD

      Affiliations

    • University of California at San Francisco, San Francisco, CA
    • ,
  • Richard J. Martin, MD

      Affiliations

    • Case Western Reserve University, Cleveland, OH
    • ,
  • William E. Truog, MD

      Affiliations

    • University of Missouri-Kansas City, Kansas City, MO
    • ,
  • Philip L. Ballard, MD, PhD

      Affiliations

    • University of California at San Francisco, San Francisco, CA
    • ,
  • Arlene Zadell, RN

      Affiliations

    • Case Western Reserve University, Cleveland, OH
    • ,
  • Sandra R. Wadlinger, MS, RRT

      Affiliations

    • The Children's Hospital of Philadelphia, Philadelphia, PA
    • ,
  • Christine E. Coburn, MSN

      Affiliations

    • The Children's Hospital of Philadelphia, Philadelphia, PA
    • ,
  • Roberta A. Ballard, MD

      Affiliations

    • University of California at San Francisco, San Francisco, CA
    • ,
  • NO CLD Study Group

Received 13 July 2009 ,Revised 2 September 2009 ,Accepted 14 October 2009.

References 

  1. Schreiber MD, Gin-Mestan K, Marks JD, Huo D, Lee G, Srisuparp P. Inhaled nitric oxide in premature infants with the respiratory distress syndrome. N Engl J Med. 2003;349:2099–2107
  2. Mestan KK, Marks JD, Hecox K, Huo D, Schreiber MD. Neurodevelopmental outcomes of premature infants treated with inhaled nitric oxide. N Engl J Med. 2005;353:23–32
  3. Kinsella JP, Cutter GR, Walsh WF, Gerstmann DR, Bose CL, Hart C, et al. Early inhaled nitric oxide therapy in premature newborns with respiratory failure. N Engl J Med. 2006;355:354–364
  4. Van Meurs KP, Wright LL, Ehrenkranz RA, Lemons JA, Ball MB, Poole WK, et al. Inhaled nitric oxide for premature infants with severe respiratory failure. N Engl J Med. 2005;353:13–22
  5. Hintz SR, Van Meurs KP, Perritt R, Poole WK, Das A, Stevenson DK, et al. Neurodevelopmental outcomes of premature infants with severe respiratory failure enrolled in a randomized controlled trial of inhaled nitric oxide. J Pediatr. 2007;151:16–2222.e1-3
  6. Huddy CL, Bennett CC, Hardy P, Field D, Elbourne D, Grieve R, et al. The INNOVO multicentre randomized controlled trial: neonatal ventilation with inhaled nitric oxide versus ventilatory support without nitric oxide for severe respiratory failure in preterm infants: follow up at 4-5 years. Arch Dis Child Fetal Neonatal Ed. 2008;93:F430–F435
  7. Ballard RA, Truog WE, Cnaan A, Martin RJ, Ballard PL, Merrill JD, et al. Inhaled nitric oxide in preterm infants undergoing mechanical ventilation. N Engl J Med. 2006;355:343–353
  8. Ballard RA. Inhaled nitric oxide in preterm infants—correction. N Engl J Med. 2007;357:1444–1445
  9. Zupancic J, Hibbs A, Palermo L, Martin R, Truog W, Cnaan A, et al. Economic evaluation of inhaled nitric oxide in ventilated preterm infants. Pediatrics. 2009;In press
  10. Hibbs AM, Walsh MC, Martin RJ, Truog WE, Lorch SA, Alessandrini E, et al. One-year respiratory outcomes of preterm infants enrolled in the Nitric Oxide (to prevent) Chronic Lung Disease Trial. J Pediatr. 2008;153:525–529
  11. Truog WE, Ballard PL, Norbert M, Golombek S, Savani RC, Merrill JD, et al. Inflammatory markers and mediators in tracheal fluid of premature infants treated with inhaled nitric oxide. Pediatrics. 2007;119:670–678
  12. Ballard PL, Truog WE, Merrill JD, Gow A, Posencheg M, Golombek SG, et al. Plasma biomarkers of oxidative stress: relationship to lung disease and inhaled nitric oxide therapy in premature infants. Pediatrics. 2008;121:555–561
  13. Ballard PL, Merrill JD, Truog WE, Godinez RI, Godinez MH, McDevitt TM, et al. Surfactant function and composition in premature infants treated with inhaled nitric oxide. Pediatrics. 2007;120:346–353
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  21. Skidmore MD, Rivers A, Hack M. Increased risk of cerebral palsy among very low-birthweight infants with chronic lung disease. Dev Med Child Neurol. 1990;32:325–332
  22. Hibbs AM, Black D, Palermo L, Cnaan A, Truog W, Martin RJ, et al. The importance of accounting for multiple births in neonatal and perinatal studies: a case study and systematic review. J Pediatr. 2009;In press

 Supported by grants (U01-HL62514, P50-HL56401, P30- HD26979, MRDDRC-P30, and HD26979) from the National Institutes of Health and grants (M01-RR00240, M01-RR00084, M01-RR00425, M01-RR001271, M01-RR00064, and M01-RR00080) from the General Clinical Research Centers Program. Inhaled nitric oxide and the delivery system for the initial trial and support for completion and analysis of follow-up data were provided by INO Therapeutics (now IKARIA). The company was not involved in study design, safety monitoring, data analysis, data interpretation, or manuscript preparation. A.H. was supported by a Career Development award (NICHD K23 HD056299). R.B. received unrestricted grant support for additional biostatistical analyses of the trial from iNO Therapeutics (now IKARIA). M.W. received support from iNO Therapeutics to fund the research nurse coordinator for follow-up of this trial. The authors declare no other conflicts of interest.

 Registered at ClinicalTrials.gov (NCT00000548).

PII: S0022-3476(09)01025-7

doi: 10.1016/j.jpeds.2009.10.011

The Journal of Pediatrics
Volume 156, Issue 4 , Pages 556-561.e1 , April 2010

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